Related Information

Complete Report

Summary

WHY WE DID THIS STUDY

We conducted this analysis in 2013 at the request of a Member of Congress, and we shared our findings with the requestor and with the Department. We are issuing this report to present our findings publicly. The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT)-funded by the National Institute of Child Health and Human Development, part of the National Institutes of Health (NIH)-took place between 2005 and 2009. In May 2011, OHRP received a complaint regarding the use of informed consent in SUPPORT. OHRP responded to the complaint by conducting a compliance evaluation of SUPPORT.

HOW WE DID THIS STUDY

We reviewed how OHRP conducted its for-cause compliance evaluation of SUPPORT. We assessed how OHRP followed its 11 procedural steps and how the agency exercised its discretion. We reviewed documents provided by OHRP, including email and written communication of relevant OHRP staff involved in the SUPPORT compliance evaluation and study documents that OHRP reviewed as part of its evaluation. We also reviewed the minutes for meetings of the study's Data Safety Monitoring Committee. In addition, we conducted structured interviews with OHRP and relevant NIH staff.

WHAT WE FOUND

We found that OHRP followed its procedures and exercised discretion throughout its evaluation of SUPPORT. Generally, OHRP sees its role as educational and sees such evaluations as opportunities to strengthen human subjects protections in future research. The events following OHRP's determination in SUPPORT have raised important questions about the protection of human subjects in research that compares treatments within the current standard of care.